Ponderano

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

Researchers are evaluating the safety and effectiveness of KarXT in preventing relapse of psychosis symptoms in people aged 55 to 90 years who have psychosis associated with Alzheimer's Disease. This Phase 3 study is randomized, double-blind, placebo-controlled, and conducted at multiple outpatient centers. The main goal is to compare relapse prevention between KarXT treatment and placebo over 38 weeks, while also assessing time to discontinuation, safety, and tolerability. Participants receive either KarXT in varying doses (ranging from 20 mg/2 mg to 66.7 mg/6.67 mg taken three times daily) or placebo capsules. The study lasts 38 weeks, during which participants remain on assigned treatment in an outpatient setting. The randomized, double-blind design ensures neither participants nor researchers know who receives KarXT or placebo during the study. Throughout the study, participants will visit the clinic regularly for assessments of their psychosis symptoms, safety checks, and overall health. Researchers will track the time to relapse of psychosis symptoms as the primary outcome. They will also monitor safety and tolerability through clinical examinations and other evaluations. The total duration of participation is 38 weeks from randomization to the end of the study period.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 who have mild to severe Alzheimer's Disease (AD) accompanied by moderate to severe psychosis related to AD. This phase 3 study aims to better understand how KarXT compares to a placebo in treating the psychotic symptoms associated with Alzheimer's Disease. Participants must have documented AD diagnosis and a history of psychotic symptoms lasting at least two months prior to starting the study. Participants will receive either KarXT or a placebo, with specified doses given on designated days. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups to assess the treatment's effects. Details about dosing schedules and administration are planned but not specified here. During the study, researchers will measure changes from baseline in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score up to week 14 to evaluate the impact on psychosis symptoms. Participants will undergo brain imaging (MRI or CT) if not already done within the past five years to rule out other conditions, and safety monitoring including laboratory tests will be conducted. The total participation duration covers screening through at least 14 weeks of treatment and assessment.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are evaluating a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants who are at least 35 weeks gestational age. This study aims to assess the feasibility, safety, and accuracy of this wireless system compared to the standard wired vital sign monitors, focusing on measurements immediately after delivery and during the first two hours of life while infants remain in the obstetrical center under unsupervised parental care. The study addresses the critical need for better monitoring to prevent Sudden Unexpected Postnatal Collapse (SUPC), a serious condition occurring in newborns during early postnatal life. The study involves placing both the wireless monitoring system and the standard wired system simultaneously on each newborn's chest and limb. The wireless system includes a chest sensor called Anne Arc and a pulse oximeter limb sensor named RAD-7, while the wired system uses a standard ECG and SpO2 monitor. Vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature are monitored continuously for two hours immediately after delivery. Participants will have their vital signs tracked by both systems for direct comparison, with researchers evaluating usability, safety (including skin reactions and pain), and accuracy of the wireless system over six months. Outcomes include feasibility measures like data gaps and user satisfaction, safety assessments such as skin scores and clinical event discrepancies, and accuracy metrics like correlation and bias. This comprehensive monitoring aims to support improved neonatal care and potentially reduce risks associated with SUPC.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating treatment options for patients with advanced or metastatic pancreatic adenocarcinoma who have not experienced disease progression after 3 months of induction chemotherapy with mFOLFIRINOX. This phase III, randomized, open-label trial compares switch maintenance therapy using gemcitabine plus nab-paclitaxel against continued treatment with modified FOLFIRINOX. The study aims to determine which approach better supports overall survival in this patient population. The initial induction treatment consists of mFOLFIRINOX given every two weeks for up to 14 weeks (approximately 6 cycles). Patients showing complete or partial response, stable disease, or no progression after at least 4 cycles are randomized 1:1 to either continue modified FOLFIRINOX or switch to gemcitabine plus nab-paclitaxel. The switch maintenance therapy is administered on days 1, 8, and 15 of 28-day cycles. Stratification during randomization considers performance status and disease extent. Participants will undergo radiological tumor assessments before and after induction chemotherapy. Throughout the study, researchers will monitor overall survival up to 48 months from randomization. Safety and treatment effects are assessed regularly, and patients must meet specific health and laboratory criteria to participate. The study involves comprehensive monitoring to evaluate treatment impact and patient status during and after therapy.

Undergoing medical procedures like elective coronary angiography can cause significant emotional stress, including anxiety, fear, anger, and depression, which may negatively affect recovery and clinical outcomes. Preoperative anxiety is common and can lead to complications such as hemodynamic instability and increased medication needs. This research aims to evaluate how hypnotic communication, a non-drug method using empathetic and suggestion-based language, impacts emotional distress during coronary angiography in adult patients. Participants will be randomly assigned to either an experimental group receiving hypnotic communication alongside standard care or a control group receiving standard care only. The hypnotic communication session, delivered by trained nurses, begins at the patient's bedside before the procedure and continues through five phases until the procedure ends. The control group will follow usual care without this communication technique. Throughout the study, patients' emotional states—including stress, anxiety, depression, anger, and need for help—will be measured immediately before preparation and 60 minutes after the procedure using the Emotion Thermometer Tool. Secondary outcomes such as post-procedure pain and satisfaction with the hypnotic communication (in the experimental group) will also be evaluated. Data collection and analysis will follow ethical guidelines, with recruitment expected to last 24 months.

Researchers are evaluating the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab compared to standard nivolumab treatments in people who have advanced melanoma that has not been treated before. This study focuses on participants who have a specific genetic marker called HLA-A*02:01 and aims to understand how these treatments affect the progression of their cancer. The study is a phase 3, randomized, controlled trial, which helps ensure reliable comparison between the different treatment regimens. Participants in this study will receive either brenetafusp plus nivolumab or standard nivolumab regimens, which may include nivolumab alone or in combination with relatlimab. These treatments are given by intravenous infusion, with specific dosing of the drugs as concentrates for infusion. The study compares these approaches to see which is more effective in controlling the melanoma. During the study, participants will be closely monitored for disease progression and overall health. Researchers will use scans and other assessments to measure progression-free survival, which is the time participants live without their disease worsening, followed for up to about 45 months. Safety and response to treatment will be regularly evaluated to better understand the effects of the therapies over time.